drugset / Trial / NCT00399087

Phase I Trial of Docetaxel With Perifosine

NCT00399087

Phase 1 Completed 39 enrolled AEterna Zentaris
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a study of the drug perifosine given in combination with docetaxel. Perifosine is an oral anti-cancer agent that has been used in more than 140 people. Docetaxel is a standard chemotherapy agent used in many types of cancer. This study is designed to determine the highest dose of perifosine that can be administered to people every day while they are receiving docetaxel with or without a steroid called prednisone, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day.

Timeline

Start
2004-11
Primary completion
2010-01
Completion
2011-01

Publications

  • Results Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13066

Drugs

EvaluationDrugModalityDoseRoute
Subject Perifosine Small molecule 50 mg Oral
Subject Perifosine Small molecule 900 mg Oral
Subject Perifosine Small molecule 1200 mg Oral
Subject Perifosine Small molecule 1500 mg Oral
Subject Prednisone Other / unclassified 5 mg Oral
Background Docetaxel Small molecule 75 mg/m2 Intravenous

Indications